MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 629029

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

The customer reported burning odor and a pop sound from the instrument involving the unicel dxh 800 coulter cellular analysis system.The operator was wearing a laboratory coat at the time of the event.There was no operator injury or adverse effect associated with this event.There was no report of impact to patient results.Patient care was not affected.The customer stated there was no smoke, sparks, or flames and the fire department was not requested.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) discovered a charred f1 fuse in the electrical power supply.The fse replaced the electrical power supply and resolved the reported issue.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, the likely cause of the event is attributed to the electrical power supply.A definitive root cause is unknown.(b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4042846
• MDR Text Key: 4803175
• Report Number: 1061932-2014-02119
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K120771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1